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Details:
Mycophenolate mofetil is an immunosuppressive agent act as the inosine monophosphate dehydrogenase (IMPDH) inhibitor, which is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Lead Product(s): Mycophenolate Mofetil
Therapeutic Area: Immunology Product Name: CellCept-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 2023
Details:
Lupkynis (voclosporin) is a calcineurin-inhibitor of calcineurin. The immunosuppressant activity results in inhibition of lymphocyte proliferation, T-cell cytokine production, and expression of T-cell activation surface antigens. Currently being developed for lupus nephritis.
Lead Product(s): Voclosporin,Mycophenolate Mofetil,Undisclosed
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: PreclinicalProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 11, 2023
Details:
Lupkynis (voclosporin) is a calcineurin-inhibitor of calcineurin. The immunosuppressant activity results in inhibition of lymphocyte proliferation, T-cell cytokine production, and expression of T-cell activation surface antigens. Currently being developed for lupus nephritis.
Lead Product(s): Voclosporin,Mycophenolate Mofetil,Undisclosed
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: PreclinicalProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 24, 2023
Details:
LUPKYNIS (voclosporin) is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney.
Lead Product(s): Voclosporin,Mycophenolate Mofetil
Therapeutic Area: Immunology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 20, 2022
Details:
LUPKYNIS (voclosporin) is first FDA-approved structurally modified calcineurin inhibitor for treatment of patients with active lupus nephritis, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production.
Lead Product(s): Voclosporin,Mycophenolate Mofetil
Therapeutic Area: Immunology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2022
Details:
Lupkynis (voclosporin), is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney.
Lead Product(s): Voclosporin,Mycophenolate Mofetil
Therapeutic Area: Immunology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 04, 2022
Details:
Study demonstrated that NK cells when stimulated with a cytokine cocktail developed a memory-like phenotype with increased expansion and persistence in vivo, as a treatment for cancer of its m-ceNK platform combined with IL-15 superagonist cytokine fusion protein Anktiva™.
Lead Product(s): Inbakicept,Tacrolimus,Mycophenolate Mofetil
Therapeutic Area: Oncology Product Name: Anktiva
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2022
Details:
The analysis indicated that CFZ533 (iscalimab)-based treatment is less efficacious compared to tacrolimus-based treatment in the prevention of organ rejection in patients receiving a kidney transplant.
Lead Product(s): Iscalimab,Mycophenolate Mofetil,Corticosteroid
Therapeutic Area: Immunology Product Name: CFZ533
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2021
Details:
The “COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders” trial will study the antibody response to an extra shot of an authorized or approved COVID-19 vaccine in people with an autoimmune disease whose body did not respond to an original vaccine regimen.
Lead Product(s): mRNA-1273,Mycophenolate Mofetil
Therapeutic Area: Infections and Infectious Diseases Product Name: mRNA-1273
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 02, 2021
Details:
Leading those recommendations is Roche’s Enspryng (satralizumab), which received a positive opinion for the treatment of the rare autoimmune disease neuromyelitis optica spectrum disorders (NMOSD).
Lead Product(s): Satralizumab,Azathioprine,Mycophenolate Mofetil
Therapeutic Area: Neurology Product Name: Enspryng
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2021
Details:
Under the terms of the agreement, Catalent will manufacture LUPKYNIS as a softgel dosage form at its pharmaceutical softgel center of excellence in St. Petersburg, Florida.
Lead Product(s): Voclosporin,Mycophenolate Mofetil
Therapeutic Area: Nephrology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Aurinia Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 18, 2021
Details:
U.S. Food and Drug Administration (FDA) approved the use of Aurinia Pharmaceuticals' LupkynisTM (voclosporin) as the first oral treatment developed specifically for adults with active lupus nephritis (LN) in combination with standard of care.
Lead Product(s): Voclosporin,Mycophenolate Mofetil
Therapeutic Area: Immunology Product Name: Lupkynis
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 22, 2021
Details:
Mycophenolate Mofetil Tablets USP, 500 mg, are the generic equivalent of CellCept® Tablets of Roche Palo Alto, indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants and to be used with other immunosuppressants.
Lead Product(s): Mycophenolate Mofetil,Cyclosporine,Corticosteroids
Therapeutic Area: Immunology Product Name: Mofecon
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 29, 2020
Details:
Reducing Immunogenicity of Pegloticase demonstrated that 86.4 percent of patients receiving co-therapy of KRYSTEXXA with the immunomodulator mycophenolate mofetil achieved serum uric acid (sUA) ≤ 6 mg/dL through Month 3, the primary endpoint of the study.
Lead Product(s): Pegloticase,Mycophenolate Mofetil
Therapeutic Area: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2020
Details:
Integrated analysis confirms statistically superior efficacy and safety of voclosporin in combination with MMF and steroids over standard-of-care.
Lead Product(s): Voclosporin,Mycophenolate Mofetil
Therapeutic Area: Immunology Product Name: ISA247
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
Additional studies on the concomitant use of KRYSTEXXA (pegloticase injection) with an immunomodulator to optimize the treatment for people living with chronic gout refractory to conventional therapies (also known as uncontrolled gout) will also be presented.
Lead Product(s): Pegloticase,Mycophenolate Mofetil
Therapeutic Area: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 08, 2020
Details:
Mycophenolate Mofetil Tablets are indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.
Lead Product(s): Mycophenolate Mofetil,Cyclosporine,Corticosteroids
Therapeutic Area: Immunology Product Name: Mofecon
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2020
Details:
Entero will be responsible for promotion, marketing and distribution of Roche Pharma’s key nephrology drugs viz., Mycophenolate Mofetil (Cellcept), Valganciclovir (Valcyte), Epoetin Beta (NeoRecormon), and Methoxy Polyethylene Glycol-epoetin Beta (Mircera) in India.
Lead Product(s): Mycophenolate Mofetil
Therapeutic Area: Immunology Product Name: Cellcept
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: F. Hoffmann-La Roche
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 18, 2020
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